Abstract
Following a review of legal issues concerning the significance of capacity and consent in the context of clinical research involving groups of patients where some may be incompetent, the question is addressed how those involved in this area resolve the problems. Responses from 101 Local Research Ethics Committees, 13 pharmaceutical companies and 10 researchers engaged in work involving patients with Alzheimer's Disease indicate a considerable variation in approaches to the legal and ethical issues, as well as a degree of conflict concerning the assessment of patients' capacity to consent. The conclusion is that recent proposals from the Law Commission in this area need further consideration and elaboration in several respects.
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